Janssen Research and Development, L.L.C., a member of Johnson
and Johnson's Family of Companies, is recruiting for an Associate
Director, Clinical Development, Immunology, to be located in
Cambridge, MA, or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We
focus on treating, curing and preventing some of the most
devastating and complex diseases of our time. And we pursue the
most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical
needs in the following therapeutic areas: immunology, oncology,
neuroscience, infectious diseases & vaccines, cardiovascular &
metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more
We are Janssen. Our mission drives us. Our patients inspire us.
We collaborate with the world for the health of everyone in it. We
are guided by our Credo. https://www.jnj.com/credo/
Thriving on a diverse company culture, celebrating the
uniqueness of our employees and committed to inclusion. Proud to be
an equal opportunity employer.
The focus of the Director/Study Responsible Scientist (SRS) is
to support various clinical research tasks associated with assigned
Immunology Development clinical trials. Scope of work will include
tasks associated with the execution, monitoring, and reporting
results of clinical trials evaluating therapeutics in immunologic
disorders. The range of tasks may vary to some degree depending on
the therapeutic area and trial-specific requirements.
The Director/SRS is a key member of development clinical trial
teams and leads the team designing and execution of clinical
studies outlined in the product development plan (PDP). This work
is at its core a deep collaboration between Disease Area experts,
Early and Late Development, Translational Science (Biomarker)
experts, Immunologic Pathway experts and many other essential
development functions. The SRS partners with Global Development
Operations (GDO) and the entire Trial Team to efficiently and
effectively operationalize the studies. The Director/SRS will also
work closely with cross functional partners to support clinical
- Activities which support the execution, monitoring, and
reporting of clinical trials.
- Member of the cross-functional clinical trial team for assigned
- Participation in the development of clinical study documents
(e.g., protocols, informed consent documents, case report
- Support activities related to the start-up and execution of new
- Performing clinical data review and assist in the preparation
of clinical safety presentations and reports.
- Set up medical monitoring data review activities.
- Tracking of safety events, review of new SAEs, and composing
adverse event Narratives.
- Support preparation of the clinical content of drug safety
documents and reports such as the investigator brochures, DSURs,
and other regulatory response documents.
- Assist with managing other vendor activities such as
laboratory, histology or imaging.
- In collaboration with GDO, identifying clinical sites and CROs
that will participate in trials.
- Interact with staff responsible for the design, set-up,
execution, analysis and reporting of these studies.
- Review incoming data from the study for accuracy and
- Participate in the review and interpretation of clinical trial
data to enable timely internal decision-making and external
communication with investigators and regulatory agencies.
- Participate in the preparation and assure the accuracy of the
clinical study report and any external publications.
- Report the status of clinical trials to management.
- BS, MS, PharmD, PhD or RN preferably with a scientific
background in Immunology or a related field, and 7 -10 years
industry experience or equivalent clinical research experience is
- Experience with Ph 2 and Ph 3 studies in immunology indications
- Ability to survey and interpret the scientific literature
related to the assigned projects is required.
- Strong organizational skills and the ability to work well in a
dynamic environment and be able to prioritize and respond to
changing needs of the business.
- Good interpersonal skills and the ability to advise, persuade,
and negotiate with colleagues in a supportive and encouraging
- Excellent written and verbal English communication skills.
- The ability to work in a global matrix organization with
cross-functional teams is required.
- Willingness and ability to travel including international
travel is required.
- Proficient with Microsoft Office applications EXCEL,
POWERPOINT, and WORD.
- Up to 15% domestic/international travel may be required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, age, national origin, or protected
veteran status and will not be discriminated against on the basis
United States-Massachusetts-Cambridge-MA Cambridge Binney
Janssen Research & Development, LLC (6084)